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Respiratory Microbiome and COPD Exacerbations (RESMECOPD)

Respiratory Microbiome and COPD Exacerbations

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03432234
Acronym
RESMECOPD
Enrollment
120
Registered
2018-02-14
Start date
2016-03-07
Completion date
2020-12-31
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exacerbation COPD, Pulmonary Disease, Chronic Obstructive

Keywords

COPD, Microbiome, Exacerbation

Brief summary

The global objective of this coordinated project is to test the following hypotheses: 1) the lung microbiome in chronic obstructive pulmonary disease (COPD) is different in patients suffering from frequent exacerbations (FE) compared those who do not (NE ); 2) The microbial profile of patients with FE is associated with a different local and systemic inflammatory pattern; and 3) the inflammatory and immune characteristics of COPD are modulated by the intestinal microbiome. The project is based on bronchoalveolar lavage (BAL) for sampling lung microbiome, and includes analysis of regional variability (intrapulmonary) and temporal variability. The project will also assess the correlation between BAL samples obtained from the proximal airway (oral cavity, oropharynx and sputum), and the representation of lung microbiome in them. A cohort of COPD patients (n = 50 FE; n = 50 NE) and healthy subjects (n= 30), matched by age, sex and tobacco consumption. Respiratory secretion samples will be collected in clinical stability samples, with resampling in a quarter of the participants at 6-9 months. Coordinator Project: Bacterial and fungal microbiota will be determined by 16S rRNA and ITS amplification and sequencing. Virome and functional metagenomics will be analyzed in a quarter of the participants. Subprojects: Regional variability in the lung, local and systemic inflammatory response, and the relationship between the intestinal microbiome and inflammatory and clinical characteristics of the disease will be determined. The integration of the results will be performed using network medicine methodologies. The results of this project will help to understand the pathogenesis of COPD and its exacerbations with the final aim to identify new therapeutic targets.

Interventions

OTHERBiomarkers

This is an observational study, there is no intervention

Sponsors

Hospital de Sant Pau
CollaboratorOTHER
Hospital Clinic of Barcelona
CollaboratorOTHER
Hospital Universitari de Bellvitge
CollaboratorOTHER
Hospital del Mar
CollaboratorOTHER
Germans Trias i Pujol Hospital
CollaboratorOTHER
Hospital Arnau de Vilanova
CollaboratorOTHER
Centre for Genomic Regulation
CollaboratorUNKNOWN
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Spirometry: FEV1/FVC \< 70%; FEV1 between 50 and 80% predicted (GOLD II/III) * Clinical Stability (no therapeutic change and/or use of antibiotics) during 8 weeks. - The treatment received will be registered for post-hoc studies stratified by this condition.

Exclusion criteria

* Drug addiction, alcohol abuse, * Use of long-term oral or nebulised antibiotic therapy. * History of allergies, asthma or other chronic respiratory disease, sanitary worker, working exposure to dust or fumes. * Other diseases: Severe cardiovascular, neurological, psychiatric, renal, hepatic or gastrointestinal , that might interfere with the daily life activities.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory Microbiome in COPD patients with FE and NE.7 daysRespiratory Microbiome composition will be determined by using metagenomic aproaches.

Secondary

MeasureTime frameDescription
Bacteria related to pulmonary and systemic inflamatory factors (FE vs NE)7 daysDetermination of pulmonary and systemic markers with ELISA kit. Microbiome will be determined by metagenomic techniques.
Longitudinal variability of respiratory microbiome in COPD patients (FE vs NE).12 monthsChange of respiratory Microbiome (diversity and abundance)
Inmunological response of lung epithelial cells COPD patients after an infectious and inflammatory stimuli7 daysThe in vitro response of epithelial cells will be determined with ELISA kits.

Other

MeasureTime frameDescription
Spatial variability of respiratory microbiome in COPD patients (FE vs NE).1 dayRespiratory Microbiome Composition of different types of samples.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026